UNIK NYLON BLUE MONO SUTURE WITH NEEDLE

Brand: UNIK Nylon Blue Monofilament Suture (UNIK Surgical Sutures / UNIMED)

Active Ingredient(s) & Strength: Non-absorbable Synthetic Monofilament Polyamide (Nylon 6 / Nylon 6.6)

Indication / Intended Use: Designed for smooth passage through tissue in general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, neurological, and plastic/cosmetic surgical procedures.

Dosage Form & Pack Size: Sterile Non-Absorbable Suture with Attached Stainless Steel Needle; 12 pieces or 24 pieces per box (varies by pack size)

Variants & Needle Specifications:

• NC164: 19mm 3/8 Circle Reverse Cutting Needle, Suture Length 75cm (USP Size: 4-0)
• NC165: 19mm 3/8 Circle Reverse Cutting Needle, Suture Length 75cm (USP Size: 3-0)
• NC193L: 24mm 3/8 Circle Reverse Cutting Needle, Suture Length 75cm (USP Size: 3-0)
• NC242: 30mm 3/8 Circle Reverse Cutting Needle, Suture Length 75cm (USP Size: 2-0)

Dosage & Administration: Single-use surgical device. To be used only by trained medical or surgical professionals in sterile procedure settings. Select appropriate suture size and needle shape based on target tissue and surgical protocol.

Target Audience / Age Limit: For use on adult and pediatric patients undergoing surgical wound closure or tissue approximation.

Precautions & Warnings:

• Single-Use Only: Do not re-sterilize or reuse to avoid infection and material degradation.
• Sterility: Do not use if the individual pouch or seal is damaged or opened prior to use.
• As with any non-absorbable synthetic suture, gradual loss of tensile strength over time may occur in vivo.

Storage Conditions: Store below 25°C in a cool, dry place away from direct sunlight, moisture, and extreme heat.

Registration / Approval Number: MDA Reg: GC9863419-35489